Concerning the authorisation of retinyl acetate, retinyl palmitate and retinyl propionate as feed additives for all animal species
EUROPEISKA KOMMISSIONEN HAR ANTAGIT DENNA FÖRORDNING
med beaktande av fördraget om Europeiska unionens funktionssätt,
med beaktande av Europaparlamentets och rådets förordning (EG) nr 1831/2003 av den 22 september 2003 om fodertillsatser, särskilt artikel 9.2, och
(1) Förordning (EG) nr 1831/2003 innehåller bestämmelser om godkännande av fodertillsatser samt de skäl och förfaranden som gäller för sådana godkännanden. Enligt artikel 10 i den förordningen ska fodertillsatser som godkänts i enlighet med rådets direktiv 70/524/EEG utvärderas på nytt.
(2) I enlighet med direktiv 70/524/EEG godkändes vitamin A utan tidsbegränsning som fodertillsats för alla djurarter. Produkten infördes därefter i registret över fodertillsatser som en befintlig produkt, i enlighet med artikel 10.1 i förordning (EG) nr 1831/2003.
(3) I enlighet med artikel 10.2 i förordning (EG) nr 1831/2003 jämförd med artikel 7 i den förordningen har det lämnats in en ansökan om en ny utvärdering av vitamin A i form av retinylacetat, retinylpalmitat och retinylpropionat och preparat av dem som fodertillsatser för alla djurarter och, i enlighet med artikel 7 i samma förordning, om ett nytt användningsområde i dricksvatten. Sökanden begärde att dessa tillsatser skulle införas i kategorin ”näringstillsatser”. Till ansökan bifogades de uppgifter och handlingar som krävs enligt artikel 7.3 i förordning (EG) nr 1831/2003.
(4) Europeiska myndigheten för livsmedelssäkerhet (nedan kallad myndigheten) konstaterade i sitt yttrande av den 12 december 2012 att retinylacetat, retinylpalmitat och retinylpropionat under föreslagna villkor för användning i foder inte inverkar negativt på djurs och människors hälsa eller på miljön.
(5) Myndigheten konstaterade även att retinylacetat, retinylpalmitat och retinylpropionat är effektiva källor till vitamin A och drog slutsatsen att det inte skulle uppstå några säkerhetsrisker för användarna. Myndigheten anser inte att det behövs några särskilda krav på övervakning efter utsläppandet på marknaden. Den bekräftade även den rapport om analysmetoden för fodertillsatserna i foder som lämnats av det referenslaboratorium som inrättats genom förordning (EG) nr 1831/2003.
(6) Bedömningen av retinylacetat, retinylpalmitat och retinylpropionat visar att villkoren för godkännande i artikel 5 i förordning (EG) nr 1831/2003 är uppfyllda, utom när det gäller dricksvatten. Ämnena bör därför godkännas för användning i foder i enlighet med bilagan till den här förordningen. Det bör fastställas högsta tillåtna halter för vitamin A oberoende av form. Vitamin A bör inte administreras direkt via dricksvatten, eftersom ytterligare en administreringsväg skulle öka risken för konsumenterna. Därför bör godkännandet för retinylacetat, retinylpalmitat och retinylpropionat som näringstillsatser i den funktionella gruppen ”vitaminer, provitaminer och kemiskt väldefinierade ämnen med likartad effekt” inte gälla för användning i vatten. Förbudet gäller inte om tillsatserna förekommer i en foderblandning som administreras via vatten.
(7) Eftersom det inte finns några säkerhetsskäl som kräver att ändringarna av villkoren för godkännandet tillämpas omedelbart, bör en övergångsperiod medges så att de berörda parterna kan anpassa sig till de nya krav som följer av godkännandet.
(8) De åtgärder som föreskrivs i denna förordning är förenliga med yttrandet från ständiga kommittén för växter, djur, livsmedel och foder.
HÄRIGENOM FÖRESKRIVS FÖLJANDE.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, in particular Article 9(2) thereof,
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC.
(2) Vitamin A was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was subsequently entered in the Register of feed additives as existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of vitamin A in the form of retinyl acetate, retinyl palmitate and retinyl propionate as feed additives and their preparations for all animal species and, in accordance with Article 7 of that Regulation, for a new use in water for drinking. The applicant requested these additives to be classified in the additive category ‘nutritional additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 December 2012 that, under the proposed conditions of use in feed, retinyl acetate, retinyl palmitate and retinyl propionate do not have an adverse effects on animal health, human health or the environment.
(5) The Authority further concluded that retinyl acetate, retinyl palmitate and retinyl propionate are effective sources of vitamin A and that no safety concerns would arise for users. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6) The assessment of retinyl acetate, retinyl palmitate and retinyl propionate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied except for water for drinking. Accordingly, the use of these substances should be authorised in feed as specified in the Annex to this Regulation. Maximum contents should be set for vitamin A irrespective of its form. Vitamin A should not be administered directly via water for drinking because an additional route of administration would increase the risk for consumers. Therefore, the authorisation of retinyl acetate, retinyl palmitate and retinyl propionate as nutritional additives belonging to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’ should be denied as regards their use in water. This prohibition does not apply to those additives within a compound feed subsequently administered via water.
(7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article1¶
The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, are authorised as additives in animal nutrition subject to the conditions laid down in that Annex.
Article2¶
Authorisation of retinyl acetate, retinyl palmitate and retinyl propionate, as additives belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is denied for use in water.
Article3¶
Ändrad genom rättelse till förordning (EU) 2015/724.
The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 26 November 2015 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted.
Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 26 May 2016 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 26 May 2017 in accordance with the rules applicable before 26 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article4¶
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX
| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|---|
| IU of vitamin A/kg of complete feedingstuff with a moisture content of 12 % | |||||||||
| 3a672a | — | ‘Retinyl acetate’, or ‘Vitamin A’ | Additive composition Retinyl acetate Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg Characterisation of the active substance Retinyl acetate C22H32O2 CAS No: 127-47-9 Retinyl acetate, solid form, produced by chemical synthesis. Purity criteria: min. 95 % (min. 2,76 MIU/g). Methods of analysis For the determination of Vitamin A in the feed additive: thin Layer Chromatography and UV detection (TLC-UV) (Ph. Eur. 6th edition, monograph 0217). For the determination of Vitamin A in premixtures and feedingstuffs: Reversed Phase High Performance Liquid Chromatography (RP-HPLC) with UV or fluorescence detection — Commission Regulation (EC) No 152/2009. | Piglets (suckling and weaned) | — | — | 16000 | 1. The additive shall be incorporated into the feed via a premixture. 2. Retinyl acetate may be placed on the market and used as an additive consisting of a preparation. 3. For the content, as set out on the label the following equivalency shall be used: 1IU = 0,344 μg retinyl acetate. 4. The mixture of retinyl acetate, retinyl palmitate or retinyl propionate shall not exceed the maximum content for the relevant species and categories. 5. In the directions for use of the additive and premixtures indicate storage and stability conditions. 6. For safety: breathing protection, safety glasses and gloves shall be worn during handling. | 26 May 2025 |
| Pigs for fattening | — | — | 6500 | ||||||
| Sows | — | — | 12000 | ||||||
| Other pigs | — | — | — | ||||||
| Chickens and minor poultry species | ≤ 14 days | — | 20000 | ||||||
| > 14 days | — | 10000 | |||||||
| Turkeys | ≤ 28 days | — | 20000 | ||||||
| > 28 days | — | 10000 | |||||||
| Other poultry | — | — | 10000 | ||||||
| Dairy cows and cows for reproduction | — | 9000 | |||||||
| Calves for rearing | 4 months | — | 16000 | ||||||
| Other calves and cows | — | — | 25000 | ||||||
| Lambs and kids for rearing | ≤ 2 months | — | 16000 | ||||||
| > 2 months | — | — | |||||||
| Cattle, sheep and goats for fattening | — | — | 10000 | ||||||
| Other bovines, sheep and goats | — | — | — | ||||||
| Mammals | — | — | Milk replacers only: 25000 | ||||||
| Other animal species | — | — | — | ||||||
| 3a672b | ‘Retinyl palmitate’ or ‘Vitamin A’ | Additive composition Retinyl palmitate Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg of the additive Characterisation of the active substance Retinyl palmitate C36H60O2 Cas No:79-81-2 Retinyl palmitate, solid and liquid forms, produced by chemical synthesis: min. 90 % or 1,64 MIU/g. Methods of analysis For the determination of Vitamin A in the feed additive: thin Layer Chromatography and UV detection (TLC-UV) (Ph. Eur. 6th edition, monograph 0217). For the determination of Vitamin A in premixtures and feedingstuffs: Reversed Phase High Performance Liquid Chromatography (RP-HPLC) with UV or fluorescence detection — Regulation (EC) No 152/2009. | Piglets (suckling and weaned) | — | — | 16000 | 1. The additive shall be incorporated into the feed via a premixture. 2. Retinyl palmitate may be placed on the market and used as an additive consisting of a preparation. 3. For the content, as set out on the label, the following equivalency shall be used: 1IU = 0,5458 μg retinyl palmitate. 4. The mixture of retinyl acetate, retinyl palmitate or retinyl propionate shall not exceed the maximum content for the relevant species and categories. 5. In the directions for use of the additive and premixtures indicate storage and stability conditions. 6. For safety: breathing protection, safety glasses and gloves shall be worn during handling. | 26 May 2025 | |
| Pigs for fattening | — | — | 6500 | ||||||
| Sows | — | — | 12000 | ||||||
| Other pigs | — | — | — | ||||||
| Chickens and minor poultry species | ≤ 14 days | — | 20000 | ||||||
| > 14 days | — | 10000 | |||||||
| Turkeys | ≤ 28 days | — | 20000 | ||||||
| > 28 days | — | 10000 | |||||||
| Other poultry | — | — | 10000 | ||||||
| Dairy cows and cows for reproduction | — | — | 9000 | ||||||
| Calves for rearing | 4 months | — | 16000 | ||||||
| Other calves and cows | — | — | 25000 | ||||||
| Lambs and kids for rearing | ≤ 2 months | — | 16000 | ||||||
| > 2 months | — | — | |||||||
| Cattle, sheep and goats for fattening | — | — | 10000 | ||||||
| Other bovines, sheep and goats | — | — | — | ||||||
| Mammals | — | — | Milk replacers only: 25000 | ||||||
| Other animal species | — | — | — | ||||||
| 3a672c | ‘Retinyl propionate’ or ‘Vitamin A’ | Additive composition Retinyl propionate Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg of the additive Characterisation of the active substance Retinyl propionate C23H34O2 Cas No.:7069-42-3 Retinyl propionate, liquid form, produced by chemical synthesis: min. 95 % or 2,64 MIU/g Methods of analysis For the determination of Vitamin A in the feed additive: thin Layer Chromatography and UV detection (TLC-UV) (Ph. Eur. 6th edition, monograph 0217). For the determination of Vitamin A in premixtures and feedingstuffs: Reversed Phase High Performance Liquid Chromatography (RP-HPLC) with UV or fluorescence detection — Regulation (EC) No 152/2009. | Piglets (suckling and weaned) | — | — | 16000 | 1. The additive shall be incorporated into the feed via a premixture. 2. Retinyl propionate may be placed on the market and used as an additive consisting of a preparation. 3. For the content, as set out on the label, the following equivalency shall be used: 1IU = 0,3585 μg retinyl propionate. 4. The mixture of retinyl acetate, retinyl palmitate or retinyl propionate shall not exceed the maximum content for the relevant species and categories. 5. In the directions for use of the additive and premixtures indicate storage and stability conditions 6. For safety: breathing protection, safety glasses and gloves shall be worn during handling. | 26 May 2025 | |
| Pigs for fattening | — | — | 6500 | ||||||
| Sows | — | — | 12000 | ||||||
| Other pigs | — | — | — | ||||||
| Chickens and minor poultry species | ≤ 14 days | — | 20000 | ||||||
| > 14 days | — | 10000 | |||||||
| Turkeys | ≤ 28 days | — | 20000 | ||||||
| > 28 days | — | 10000 | |||||||
| Other poultry | — | — | 10000 | ||||||
| Dairy cows and cows for reproduction | — | — | 9000 | ||||||
| Calves for rearing | 4 months | — | 16000 | ||||||
| Other calves or cows | — | — | 25000 | ||||||
| Lambs and kids for rearing | ≤ 2 months | — | 16000 | ||||||
| > 2 months | — | — | |||||||
| Cattle, sheep and goats for fattening | — | — | 10000 | ||||||
| Other bovines, sheep and goats | — | — | — | ||||||
| Mammals | — | — | Milk replacers only: 25000 | ||||||
| Other animal species | — | — | — | ||||||
1 OJ L 268, 18.10.2003, p. 29.
2 Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
3 EFSA Journal 2013;11(1):3037.
4 Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
5 Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).